WOCKAIR

Route of administration:

For inhalation use Posology Asthma WockAIR is not intended for the initial management of asthma. The required dose of the components of WockAIR is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted.

If an individual patient should require a combination of doses other than that available in the combination inhaler, appropriate doses of β2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed. Patients should be regularly reassessed by their prescriber/health care provider, so that the dose of budesonide/formoterol fumarate remains optimal.

The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When long-term control of symptoms is maintained with the lowest recommended dose, then the next step could include a test of inhaled corticosteroid alone.

When it is appropriate to titrate down to a lower strength or to prescribe a higher strength than is available for [Nationally competed name], a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower or a higher dose of the inhaled corticosteroid, respectively, is required.

In usual practice when control of symptoms is achieved with the twice-daily regimen, titration to the lowest effective dose could include budesonide/formoterol fumarate given once daily, when in the opinion of the prescriber, a long-acting bronchodilator in combination with an inhaled corticosteroid would be required to maintain control.

Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. WockAIR should be used as maintenance therapy only. 5 micrograms/inhalation delivered dose).

Recommended doses:

Adults (18 years and older): 1 inhalation twice daily. Some patients may require up to a maximum of 2 inhalations twice daily. Adolescents (12-17 years): 1 inhalation twice daily. Children under 12 years: as no data are available, WockAIR is not recommended for children younger than 12 years.

COPD Recommended doses:

Adults: 1 inhalation twice daily.

General information Special populations:

There are no special dosing requirements for elderly patients. There are no data available for use of WockAIR in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis.

Method of administration Instructions for use:

Patients should be demonstrated how to use the Forspiro inhaler and correct use should be checked regularly. The inhaler contains 60 doses of powder medicinal product in a coiled strip of foil. It has a dose counter which indicates how many doses are left counting down from 60 to 0.

When the last 10 doses have been reached the numbers will be on a red background. The inhaler is not refillable – it should be disposed of when it is empty and be replaced with a new one. Before using the inhaler • The transparent side chamber door should be opened.

• The foil strip should be removed from the side chamber by carefully tearing away the full length of strip against the ‘teeth’ of the side chamber as shown below. The strip should not be pulled or tugged. • The side chamber door should be closed and the used strip should be disposed of.

Note:

As the inhaler is used the side chamber will gradually fill up with used strip. The foil strips with black bars don’t contain medicinal product. Eventually the numbered sections of the strip will appear in the side chamber. There should never be more than 2 sections of foil strip in the side chamber as they may cause the inhaler to jam.

The strip should be torn away carefully as shown above, and disposed of safely. Using the inhaler The inhaler should be held in hands, as seen in the pictures. 1. Open • The protective cap should be opened downwards to reveal the mouthpiece.

• The dose counter should be checked to see how many doses are left. 2. Preparation of the dose • The edge of the white lever should be lifted up. The side chamber should be closed.

Note:

The white lever should only be operated when the patient is ready to inhale a dose of the medicinal product. If the patient plays with the white lever he/she will waste doses. • Open: The white lever should be moved over fully as far as it will go and until it clicks.

This action moves a new dose into position with the number at the top. • Close: Afterwards the white lever should be closed fully so that it clicks back into its original position. The inhaler is now ready for immediate use. 3. Inhalation of the dose • Away from the inhaler mouthpiece, the patient should breathe out as much as is comfortable.

It should never be breathed directly into the inhaler as this could affect the dose. • The inhaler should be hold level with the protective cap pointing downwards. • The lips should be closed firmly around the mouthpiece. • The patient should breathe in as deeply and as hard as possible through the inhaler, not through the nose.

• The inhaler should be removed from the mouth and the breath should be held for 5-10 seconds or as long as is possible without causing discomfort. • Afterwards, the patient should breathe out slowly, but not into the inhaler. • The protective cap should be closed over the mouthpiece.

• The mouth should be rinsed with water, which should be spat out afterwards. This may help to prevent getting fungal infection in the mouth and becoming hoarse. Cleaning • The outside of the mouthpiece should be wiped with a clean, dry tissue if necessary.

• The inhaler should not be taken apart to clean it or for any […]

Since WockAIR contains both budesonide and formoterol, the same pattern of undesirable effects as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.

The most common active substance-related adverse reactions are pharmacologically predictable side effects of β2 agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment.

Adverse reactions, which have been associated with budesonide or formoterol, are given below, listed by system organ class and frequency. Frequencies are defined as: very common (1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000) and very rare (< 1/10 000).

g. g. atrial fibrillation, supraventricular tachycardia, extrasystoles Cardiac disorders Very rare Angina pectoris. Prolongation of QTc- interval Vascular disorders Very rare Variations in blood pressure Common Mild irritation in the throat, coughing, dysphonia including hoarseness Respiratory, thoracic and mediastinal disorders Rare Bronchospasm Gastrointestinal disorders Uncommon Nausea Skin and subcutaneous tissue disorders Uncommon Bruises Musculoskeletal and connective tissue disorders Uncommon Muscle cramps Candida infection in the oropharynx is due to medicinal product deposition.

Advising the patient to rinse the mouth out with water after each maintenance dose will minimize the risk. Oropharyngeal Candida infection usually responds to topical antifungal treatment without the need to discontinue the inhaled corticosteroid.

If oropharyngeal thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations. As with other inhalation therapy, paradoxical bronchospasm may occur very rarely, affecting less than 1 in 10,000 people, with an immediate increase in wheezing and shortness of breath after dosing.

Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway. 4). Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids.

Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. Increased susceptibility to infections and impairment of the ability to adapt to stress may also occur.

Effects are probably dependent on dose, exposure time, concomitant and previous steroid exposure and individual sensitivity. Treatment with β2 adrenoceptor agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly. 2). Increasing use of rescue bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.

Sudden and progressive deterioration in control of asthma or COPD is potentially life threatening and the patient should undergo urgent medical assessment. g. a course of oral corticosteroids, or antibiotic treatment if an infection is present.

Patients should be advised to have their rescue inhaler available at all times. Patients should be reminded to take their WockAIR maintenance dose as prescribed, even when asymptomatic. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of WockAIR.

Regular review of patients as treatment is stepped down is important. 2). Patients should not be initiated on WockAIR during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with WockAIR .

Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of WockAIR. 1) As with other inhalation therapy, paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath after dosing.

If the patient experiences paradoxical bronchospasm WockAIR should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary. 8). Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.

These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. 8). Potential effects on bone density should be considered, particularly in patients on high doses for prolonged periods that have coexisting risk factors for osteoporosis.

Long-term studies with inhaled budesonide in children at mean daily doses of 400 micrograms (metered dose) or in adults at daily doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral density.

No information regarding the effect of WockAIR at higher doses is available. If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to WockAIR therapy.

The benefits of inhaled budesonide therapy would normally minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. Recovery may take a considerable amount of time after cessation of oral steroid therapy and hence oral steroid- dependent patients transferred to inhaled budesonide may remain at risk from impaired adrenal function for some considerable time.

In such circumstances HPA axis function should be monitored regularly. Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may also result in clinically significant adrenal suppression.

Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery. Rapid reduction in the dose of steroids can induce acute adrenal crisis. Symptoms and signs which might be seen in acute adrenal crisis may be somewhat vague but may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness, seizures, hypotension and hypoglycaemia.

Treatment with supplementary systemic steroids or inhaled budesonide should not be stopped abruptly. During transfer from oral therapy to WockAIR, a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain.

Specific treatment should be initiated for these conditions. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.

8), the patient should be instructed to rinse their mouth out with water after inhaling the maintenance dose. 5). If this is not possible the time interval between administration of the interacting medicinal products should be as long as possible.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the […]

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